Sodium‐glucose cotransporter‐2 inhibitor luseogliflozin added to glucagon‐like peptide 1 receptor agonist liraglutide improves glycemic control with bodyweight and fat mass reductions in Japanese patients with type 2 diabetes: A 52‐week, open‐label, single‐arm study

摘要

Aims/Introduction The aim of the present study was to evaluate the safety and efficacy of luseogliflozin added to liraglutide monotherapy in Japanese individuals with type 2 diabetes. Materials and Methods This 52‐week, multicenter, open‐label, single‐arm clinical study enrolled Japanese patients who had inadequate glycemic control with diet/exercise and liraglutide monotherapy. Major efficacy end‐points included the changes from baseline in glycated hemoglobin, fasting plasma glucose and bodyweight. Body composition was also assessed in individuals who had access to bioelectrical impedance analysis. Safety assessments included adverse events, clinical laboratory tests, vital signs and 12‐lead electrocardiograms. Results Of 76 patients who received luseogliflozin, 62 completed the study. The changes from baseline in glycated hemoglobin, fasting plasma glucose, and bodyweight (mean ± SE) were ?0.68 ± 0.10%, ?32.1 ± 3.6 mg/dL and ?2.71 ± 0.24 kg at week 52, respectively (all, P Conclusions Luseogliflozin added to liraglutide was well tolerated, and improved glycemic control with bodyweight and fat mass reductions in Japanese type 2 diabetes patients.